PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1320204
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1320204
Biopharmaceutical CMO And CRO Market size was valued at USD 32,478.3 Million in 2022, expanding at a CAGR of 5.5% from 2023 to 2030.
Biopharmaceutical CMO (Contract Manufacturing Organization) and CRO (Contract Research Organization) are specialized service providers within the biopharmaceutical industry that offer outsourcing solutions to biopharmaceutical companies. These CMOs have specialized facilities and expertise to manufacture a wide range of biopharmaceuticals, including biologics, vaccines, gene therapies, and other complex biological products. Biopharmaceutical CMOs play a crucial role in the production of these advanced therapeutics, as they often require sophisticated and specialized manufacturing processes. CROs on the other hand provide research and development support, conducting various phases of preclinical and clinical trials, as well as other research activities. Biopharmaceutical CROs play a critical role in advancing the drug development process by providing expertise, resources, and infrastructure for conducting clinical trials and other research studies
The year 2020 witnessed remarkable growth, primarily attributed to the impact of the COVID-19 pandemic. Prominent participants in the biopharmaceutical industry increased their investments to improve productivity and efficiency, leading bio manufacturers to shift their focus towards outsourcing activities. Currently, biopharma companies are outsourcing resource and capital-intensive steps, and in some instances, the entire biomanufacturing process, thus driving the demand for contract-based services. In recent years, the biopharmaceutical industry has experienced a significant number of consolidations, primarily driven by the aim of expanding businesses and maintaining competitiveness in the biopharmaceutical contract manufacturing and services market. While the biopharmaceutical CMO & CRO industry itself is relatively mature, the introduction of new bioprocessing tools, innovative therapeutics, and shifting priorities in the bio/pharmaceutical industry have placed additional pressure on contract biomanufacturers. Consequently, CDMOs are adopting various business models to effectively address the needs of their clients and stakeholders. Moreover, the incorporation of single-use systems in production facilities allows CMOs to economically expand their manufacturing capacity. Single-use products offer rapid turnaround times and reduce associated tasks such as cleaning and changeover validation. However, contract negotiations between CMOs and customers can be challenging due to the complexities of the regulatory landscape and services involved. Issues related to intellectual property rights, warranties & liabilities, pricing, and timelines add further complexity to these negotiations for both clients and CMOs.
The Global Biopharmaceutical CMO And CRO Market is segmented on the basis of Product Type, By Source, By Service Type, and Region.
The market is divided into two categories based on Source Type: mammalian and non- mammalian. In 2022, the mammalian segment dominated the market with a significant market share. This is mainly due to the industry's limited internal expertise, driving companies to rely on mammalian systems for their ability to introduce human-like post-translational modifications to complex protein therapeutics. Additionally, the segment has greatly benefited from the introduction of advanced expression systems, improved process monitoring solutions, cell line engineering tools, automated screening methods, and disposable devices, further bolstering its growth and success.
The market is divided into two categories based on Service type: Contract Manufacturing and Contract research. In 2022, the Contract Manufacturing segment accounted for the largest market share. On the other hand, the Contract Research segment is projected to experience the fastest CAGR during the forecast period. This growth is primarily driven by the increasing trend of biopharmaceutical companies outsourcing their research activities. Within the industry, there is a significant number of Contract Manufacturing Organizations (CMOs) and opportunistic CMOs that offer a wide array of services to biopharmaceutical entities. These services range from end-to-end coverage, starting from cell cultivation to fill/finish services. Additionally, clients are heavily investing in outsourcing the manufacturing aspect of their product development programs. This increased focus on outsourcing is contributing to the rapid growth of the Contract Research segment.
Geographically, this market is widespread into the regions of North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. These regions are further divided as per the nations bringing business.
The market exhibits a fragmented structure as it comprises a significant number of established and medium-to-small-sized CMOs and CROs. Many of these market participants are privately held or fall under the portfolios of private equity firms. In order to enhance project throughput and product quality, CMOs are increasingly adopting automation and innovative technologies at their facilities. As a result, large molecule manufacturers are becoming more interested in collaborating with CMOs to meet the rising demand for biologics.
In March 2023, Hanmi Pharmaceutical has announced its intention to take part in the 2023 BIO-Europe Spring Conference, where it will formally launch its CMO (contract manufacturing organization) and CDMO (contract development and manufacturing organization) business activities.